510(k) · Cleared
ClearedPRO-DOSE System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu-Rise, SA · NZT Dosimeter, Ionizing Radiation, Implanted
Cleared on Oct 1, 2025 as substantially equivalent to K092285 (Best Medical Canada, Ltd., 2009) after a 261-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Oct 1, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- NZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092285 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK092285 Portable Dosimeter Dose Verification System, Model TD-RD-90Best Medical Canada, Ltd. · 2009
- This deviceK250083 PRO-DOSE SystemNu-Rise, SA · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092285 | Portable Dosimeter Dose Verification System, Model TD-RD-90 | Best Medical Canada, Ltd. | 2009 | — |
| 0 (this device) | K250083 | PRO-DOSE System | Nu-Rise, SA | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NZT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K092285.
How does its category compare?
All NZT devicesNZT Dosimeter, Ionizing Radiation, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NZT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NZT
Too few NZT 510(k)s in any year since 2007 to give a median.
Recalls per year · NZT
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NZT
No MAUDE report names NZT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 5 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PRO-DOSE System is intended to provide dosimetry or detect in real-time the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of HDR brachytherapy after-loaders involving Iridium-192 sources.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250083: PRO-DOSE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026